MAUDE Adverse Event Report: KAVO DENTAL TECHNOLOGIES, LLC LIGHT FANTASTIC III; DENTAL LIGHT

Model Number LFIII

Device Problem Mechanical Problem (1384)

Patient Problem Swelling (2091)

Event Date 08/07/2018

Event Type  malfunction  

Manufacturer Narrative

The pelton & crane authorized dealer service technician informed pelton & crane that he replaced the spring assembly inside the lfiii dental light counter balance arm and then disposed of it.The dealer service technician informed pelton & crane he did not return the replaced spring assembly to pelton & crane because the light was no longer in warranty.As a result, pelton & crane is unable to evaluate the replaced spring assembly.The dental light is over 8 1/2 years old.

Event Description

A dental professional was performing routine dental care to a patient when the dental light arm assembly broke causing the light to drop down towards the ground.The dental light hit the patient on the forehead causing a small bump which the doctor treated with an ice pack.No other medical attention was required.

• Brand Name: LIGHT FANTASTIC III
• Type of Device: DENTAL LIGHT
• Manufacturer (Section D): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer (Section G): KAVO DENTAL TECHNOLOGIES, LLC; 11727 fruehauf drive; charlotte NC 28273
• Manufacturer Contact: frank ray ; 11727 fruehauf drive; charlotte, NC 28273 ; 7045877227
• MDR Report Key: 7848097
• MDR Text Key: 119501276
• Report Number: 1017522-2018-00025
• Device Sequence Number: 1
• Product Code: EAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LFIII
• Device Catalogue Number: LFIII
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1